Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06738459
• Lead Sponsor: Centro di Riferimento Oncologico - Aviano

Brief Summary

Accurate assessment of axillary lymph nodes in patients with breast cancer is essential for prognosis and treatment planning. Staging and surgical management have evolved from axillary lymph node dissection to sentinel lymph node biopsy to minimize morbidity. However, sentinel lymph node biopsy has non-negligible morbidity, and more than 70% of biopsies are negative, calling into question its routine use. Magnetic resonance imaging (MRI) can be used to detect and stage lymph node metastases in situ, but its sensitivity and specificity are moderate to poor. Few studies have employed artificial intelligence to detect lymph node metastases on MRI images, and none have used an integrative multidata approach (IMA), defined as modeling the combination of clinical and laboratory data with multiparametric MRI.

The primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients diagnosed with breast cancer who underwent MRI and biopsy or surgery of axillary lymph nodes as part of their diagnosis and treatment
• Patients of all genders, ages, and stage I-III of breast cancer
• Patients who underwent neoadjuvant therapy and have longitudinal imaging data available for analysis (for secondary outcome analysis)

Exclusion Criteria

• Patients whose MRI images were of insufficient quality for analysis
• Patients who had a previous history of breast cancer
• Patients with a history of axillary surgery or lymph node dissection prior to the current diagnosis of breast cancer
• Patients who received neoadjuvant therapy at another institution

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accuracy of detecting lymph node involvement using multiparametric MRI, clinical characteristics, and laboratory data, and to compare it to the accuracy of detecting lymph node involvement using MRI alone	up to 2 years	Sensitivity, specificity, positive predictive value, and negative predictive value of the integrative model will be calculated to evaluate the diagnostic performance of the model.

Secondary Outcome Measures

Name	Time	Method
Evaluate the association between changes in lymph node involvement and overall survival	up to 2 years	Association between changes in lymph node involvement and overall survival (OS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) OS will be calculated from neoajuvant treatment start to death or end of follow up whichever came first
Evaluate the changes in lymph node involvement over time	up to 2 years	The effects of neoadjuvant therapy will be estimated as the difference in the rate of lymph node involvement before and after neoadjuvant therapy, with corresponding 95% confidence intervals.
Evaluate the association between changes in lymph node involvement and progression free survival (PFS)	up to 2 years	Association between changes in lymph node involvement and overall survival (PFS) will be reported as Hazard Ratio and relative 95% Confidence Interval (95% CI) PFS will be calculated from neoajuvant treatment start to progression, death or end of follow up whichever came first

Trial Locations

Locations (4)

Landeskrankenhaus Villach; 🇦🇹 Villach, Austria

Klinikum Klagenfurt am Wörthersee Klagenfurt am Wörthersee; 🇮🇹 Villach, Austria, Italy

Centro di Riferimento Oncologico; 🇮🇹 Aviano, Pordenone, Italy

KI4LIFE, Fraunhofer Austria Research; 🇮🇹 Austria, Italy